Action Points

Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Note that this case-control study demonstrated similar outcomes in patients receiving transcatheter aortic valve replacement regardless of whether the procedure was live-transmitted for teaching purposes.

Although the on-camera cases took longer than off-camera cases to complete (129 versus 100.8 minutes, P=0.007), there were no significant differences in fluoroscopy time, contrast use, and length of stay in the intensive care unit or hospital, according to Ron Waksman, MD, of MedStar Washington Hospital Center in Washington, D.C.

Also, a wide range of complications occurred at similar rates in the two groups, he reported at the Society for Cardiovascular Angiography and Interventions meeting here.

"We basically think that this is a strong signal to support the continuation of live cases," Waksman said, noting a caveat: live transmissions should only be performed by operators with high volumes of both TAVI procedures and live case transmission.

If those criteria are met, "we don't see any reason to prohibit live case and we do still feel that there is a strong educational value in this approach," Waksman said, adding that the current study was designed to look only at safety.

Live case transmission has been used in interventional cardiology for 30 years, Waksman said, but concerns have been raised in recent years about patient safety. In 2010, several cardiology organizations, including the American College of Cardiology and SCAI, released a paper that noted the limited amount of data available to assess the relative risks and benefits of live case transmissions.

The FDA has an ongoing ban on live transmission of TAVI cases that involve investigational devices. When the current study was initiated, TAVI had not yet been approved in the U.S., and Waksman and his colleagues approached the agency about studying the safety of live case transmission.

With partial funding from the FDA, the researchers initiated the VERITAS study, in which six centers -- one each in the U.K., Switzerland, Germany, Canada, Italy, and the U.S. -- matched live or taped TAVI cases with similar cases that were not on camera.

The study included 46 live or taped cases and 46 off-camera controls matched according to site, operator, first attending physician, STS score (within 2 points), date of the procedure (within 4 weeks), access site, and type of valve. Another 18 live or taped cases that could not be matched were included in a registry.

All data were collected retrospectively though chart review.

The case and control patients were well matched, with a mean age of 84 in the cases and 83 in the controls. The average logistic EuroSCORE was 20.68 in the cases and 21.74 in the controls and the average STS risk score was 6.4 in each group.

At baseline, risk factor burden and echocardiographic data were similar in the two groups. Procedural characteristics were similar, as well. Most of the patients (72% of the cases and 76% of the controls) received the Edwards Sapien valve and the rest received the Medtronic CoreValve prosthesis.

There were no differences between the two groups in intraprocedural complications, including paravalvular leak, central leak, residual aortic stenosis, valve migration, coronary obstruction, device failure, valve embolism, or procedural death.

Likewise, rates of various post-procedural outcomes, including bleeding, in-hospital death, stroke, tamponade, valve embolization, coronary obstruction, renal failure requiring dialysis, the need for a pacemaker, and infection, were similar in the two groups.

"I think this is an important trial from my perspective because this is an area of a lot of primarily opinion, but strong opinion, on both sides," according to Timothy Henry, MD, director of research at the Minneapolis Heart Institute Foundation.

In an era of rapidly changing technology, he said, many doctors will need to learn about new techniques after their training has ended, so "there have to be mechanisms of how we adopt new technology and learn how to use it, and certainly in interventional cardiology this live case has been a very effective way."

"This is the first time that there's really any real data actually," Henry said, adding that he hopes the study will stimulate more analyses, especially in regard to the educational value of live case transmission.

Waksman acknowledged that the VERITAS study was limited by the retrospective data collection, the small sample size, the inability to evaluate patient satisfaction, and the inability to match all of the cases to a control.

The study was partially funded by a grant from the FDA.

Waksman reported that he had no conflicts of interest.

Reviewed by F. Perry Wilson, MD, MSCE Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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